According to the Centers for Disease Control and Prevention (CDC), the annual rate of HIV diagnoses has dropped by one third overall, falling by 33% among women, 70% in injection-drug users, 37% among black Americans and 21% for Hispanics. But HIV diagnoses for young, gay and bisexual men has been bucking this positive trend, with diagnoses doubling among those aged 13 to 24 since 2002.
Widespread HIV testing, drug-treatment programs and education are all factors influencing the slowdown in HIV diagnoses. Yet the rate of diagnosis among younger men who have sex with men (MSMs) remains stubbornly high despite these interventions, raising the question -- is it time for more widespread use of preventative HIV medications such as Gilead’s Truvada?
After 30 year of living with HIV as a clinical and social reality, educators have developed very sophisticated approaches to communicating with different target populations about the risks of having unprotected sex, as well as the risks of injection-drug use. But young men often feel immune to these risks. The era when AIDS was seen as a death sentence can feel like ancient history to many young men, who want to celebrate their sexuality and not feel constrained or stigmatized.
Unfortunately, this type of mindset may lead to HIV infection when people are not careful. Currently, 1.1 millin people in the US are living with HIV, as are more than 2.5 million people worldwide.
Statistically speaking, the rate of HIV infection should have started declining among the MSM population since at least 2012, when Truvada (tenofovir/emtricitabane) was approved by the FDA for the prevention of HIV. But in spite of well-organized educational campaigns, the drug has been slow to take hold -- only about 2,000 people are currently using Truvada preventively despite having the FDA’s blessing and available evidence showing the treatment’s efficacy.
Clinical studies have shown that when patients are adherent to this one pill, once-a-day regimen -- known as pre-exposure prophylaxis or PrEP -- their risk of becoming HIV infected decreases by a staggering 92%. That’s pretty powerful data. Unfortunately, the stigma surrounding a prescription drug that makes it possible to engage in unprotected sex has been equally powerful.
Conflicting views in the gay community
A recent New York Magazine piece by Tim Murphy tapped into the conflicted sensibilities surrounding PrEP among people in the gay community. On one hand, gay men are excited about having more tools to stay healthy and protect themselves. On the other hand, some men feel that having such assurances promotes promiscuity and does not serve the community or the individuals who rely on PrEP.
Murphy quotes one 43-year-old man as saying, “I’m not scared of sex for the first time in my life, ever. That’s been an adrenaline rush.” However, men like Larry Kramer, a well-known 79-year-old AIDS activist, have a less rosy view. “There’s something to me cowardly about taking Truvada instead of using a condom,” Kramer argued. “You’re taking a drug that is poison to you and it has lessened your energy to fight, to get involved, to do anything.”
CDC: This is a public health issue
There is controversy surrounding PrEP in major cities across the country. But the fact remains that Truvada is an FDA-approved drug for the prevention and treatment of HIV infection.
HIV is a public health issue -- especially as infection rates start to rise again among certain populations. It is in this context that the CDC issued Federal PrEP Clinical Practice Guidelines recommending that HIV-negative individuals at high risk for HIV infection should take PrEP. These groups include anyone in an ongoing relationship with an HIV-infected partner, individuals who do not use condoms when having sex with partners of unknown HIV status and injection-drug users.
Cost-benefit analysis and the human factor
The CDC PrEP guidelines have only been out for two months, but they have already been heralded by various at-risk communities and healthcare practitioners. For the most part, insurance companies and government payers cover PrEP. And when the issue of price comes up -- as it often does -- a logical comparative cost analysis is in order.
Truvada costs approximately $15,000 per year, compared with the average $23,000 annual cost of treating HIV infection, according to the AIDS Foundation of Chicago.
Truvada’s revenues were roughly $3 billion in 2013 and $750 million for the first quarter of this year. Now, with the credibility that comes with both an FDA approval and a CDC endorsement, Gilead may see a significant boost in Truvada uptake – and the drug does not go off patent until 2021. Profits notwithstanding, tens of thousands of people stand to benefit from PrEP in the coming years.